NCT00231166

Brief Summary

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2005

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

September 30, 2005

Last Update Submit

October 9, 2018

Conditions

Multiple Myeloma

Keywords

dose-findingmonoclonal antibodyMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Safety, pharmacokinetics and pharmacodynamics at multiple doses

    At the completion of each dose escalation cohort

Secondary Outcomes (1)

  • Clinical response after various doses

    Once a month

Study Arms (1)

HCD122

EXPERIMENTAL
Drug: HCD122

Interventions

HCD122DRUG
HCD122

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of MM requiring treatment
  • Refractory or Relapsed Disease
  • At least one prior treatment regimen
  • Male or Female
  • \>18 years of age

You may not qualify if:

  • Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
  • Intracranial disease or epidural disease
  • Clinically significant cardiac dysfunction or other significant organ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102

Boston, Massachusetts, 02115, United States

Location

St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer

New York, New York, 10011, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102

Philadelphia, Pennsylvania, 19104, United States

Location

Fred Hutchinson Cancer Research Center Dept. of FHCRC

Seattle, Washington, 98109, United States

Location

Novartis Investigative Site

Herston, Queensland, 4029, Australia

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

lucatumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

September 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

US(5)AU(2)